a. Field of the Invention
The present disclosure generally relates to a removable navigation system for a medical device and a navigation method for a medical device within a body. In particular, the present disclosure relates to a system in which a medical device is at least partially covered by a sheath having a positioning sensor affixed thereto and in which a deformable fixation element is used to temporarily fix a position of the sheath and positioning sensor relative to the medical device.
b. Background Art
It is well known that various diagnostic and treatment procedures are performed by inserting a medical device, such as but not limited to a catheter, guide wire or lead, through a lumen of a body of a patient, such as a blood vessel in the circulation system, the gastrointestinal tract, the brain vessels, the bronchial tree, and the like. When a surgeon is performing an operation on an artery or a vein, such as, but not limited to, angioplasty or implanting a stent within an artery, it is often necessary for the surgeon to know the position and the orientation of the tip of the inserted medical device during the operation. The position and orientation of the medical device can be determined using a variety of components affixed the medical device such as but not limited to, an electromagnetic sensor, ultrasonic sensor, or a marker attached to the medical device (e.g., a radiopaque marker).
One example of a system for determining the position and orientation of a medical device as it advances to the target location is system sold under the registered trademark “ENSITE NAVX” by St. Jude Medical, Inc. EnSite is capable of displaying 3D positions of multiple catheters. This is achieved by applying a low-level 5.6 kHz current through orthogonally-located skin patches. The recorded voltage and impedance at each catheter's electrodes generated from the low level 5.6 kHz current allows the catheter's distance from each skin patch, and ultimately, their location in space, to be triangulated with the help of a reference electrode. Three-dimensional images of each catheter can then be displayed. Respiratory motion artifact can also be eliminated to prevent confounding of actual catheter position. With respect to cardiac related procedures, heart chamber geometry can be determined thereafter by moving a mapping catheter along the endocardial surface.
The inventors herein have recognized a need for a removable navigation system for a medical device and a navigation method for a medical device within a body that will improve upon known systems and methods for tracking internal medical devices.